BioNotebook: Former Sanofi CEO Viehbacher joins PureTech board; three venture financings, four deals and a dropped drug

It didn't take long for Chris Viehbacher to jump back in to the world of drug development, although by joining the board of directors of PureTech in Boston he's swimming at the opposite end of the biopharma pool from where he was as CEO of Sanofi back in October.

PureTech isn't exactly a venture capital firm, although it incubates new biotechnology companies and prepares them for big pharma partnerships. The company develops solutions to specific health care problems then spins the medicine or medical device out into a newly created company that generally receives funding through proof-of-concept or beyond.

PureTech funds each endeavor with capital it has raised from Invesco Perpetual, strategic investors and endowments as well as founders and executives of major health care and technology companies. PureTech raised $107m between October and January to back existing programs and invest in new opportunities.

Mr Viehbacher joins Ben Shapiro, former Merck & Co executive vice president of worldwide basic and external research; John LaMattina, former president of research and development at Pfizer; and Raju Kucherlapati, co-founder of Millennium Pharmaceuticals and Abgenix, at PureTech. The company's board also includes PureTech co-founder and CEO Daphne Zohar; co-founder, Massachusetts Institute of Technology (MIT) professor and prolific biotech entrepreneur Robert Langer; and MIT professor and Nobel laureate Robert Horvitz, among other notable researchers.

After being fired by Sanofi's board of directors over declining sales growth for the diabetes blockbuster Lantus and communication issues with the board in October – and with a nearly €3m firing fee and €250,000 per month in his pocket from the French big pharma – it would seem that there was no rush for Mr Viehbacher to find a new biopharma job (scripintelligence.com, 23 January 2015).

However, he said in a statement that PureTech's "pipeline of companies is at an exciting inflection point and I think the talent within the management team and board can achieve great things."

Among PureTech's drug development opportunities is:

*Vedanta Biosciences, which is developing microbiome-derived therapies for infectious disease, allergies and autoimmune disorders, including a recently announced inflammatory bowel disease partnership with Johnson & Johnson worth up to $241m (scripintelligence.com, 14 January 2015);

*Gelesis, which is developing a novel therapy that acts in the gastrointestinal tract to cause weight loss;

*Karuna, which has a novel treatment for schizophrenia;

*Follica, whose novel treatments for baldness are based on advances in epithelial stem cell biology; and

*Entrega, a developer of oral formulations of injectable therapies that also has a delivery system for nanomedicines.

Venture and private financing: Chiasma, Lyric and Neos

Chiasma lost its partner when Roche backed away from the company's ocreotide capsules for acromegaly – an oral somatostatin analog that could replace painful injections to treat the rare disease – but the company recently revealed Phase III data that may support a new drug application (NDA) submission to the US FDA and now it has funding to submit the NDA in the second quarter of 2015, commercialize the product and advance preclinical programs (scripintelligence.com, 9 February 2015).

Newton, Massachusetts and Jerusalem-based Chiasma closed a $70m Series E venture funding round with venture capital from new investors Rock Springs Capital, Soffinova Ventures and an undisclosed blue chip public investment fund with backing from existing investors MPM Capital, F2 Capital, 7 Med Health Ventures, Abingworth and ARCH Venture Partners.

Lyric Pharmaceuticals

Lyric Pharmaceuticals in South San Francisco closed a $20.4m Series A round co-led by RiverVest Venture Partners, Sante Ventures and Third Point Ventures with participation from Aperture Venture Partners. The company launched in 2013 and closed an $825,000 seed funding round in 2014 backed by RiverVest and several angel investors. Lyric is developing therapies for gastrointestinal diseases. Its Series A cash will fund two clinical trials for the first drug candidate, which it in-licensed in September.

Neos Therapeutics

Dallas and Fort Worth, Texas-based Neos Therapeutics raised $20.6m in financing from Presidio Partners, Crabtree Partners, CAC, Delaware Street Capital, Burrill Life Sciences Capital, Essex Capital Corp and other investors to support commercialization of the company's first extended-release medicine to treat attention deficit hyperactivity disorder (ADHD). Neos submitted a new drug application (NDA) to the FDA in January for its extended-release methylphenidate formulation known as NT-0102.

The company's new funding will support operations during the FDA review process as well as the submission of two additional NDAs for extended-release oral and liquid amphetamines for ADHD. All three lead product candidates are designed for pediatric and adolescent patients that have a hard time swallowing currently available extended-release stimulant medications for ADHD.

Four deals: Ipsen/Canbex, Cipher/Astion, Aduro, Insys/Gold Coast

Ipsen recently committed significant funds to possibly buy Canbex Therapeutics; Cipher Pharmaceuticals is buying three products from Astion Pharma; Aduro Biotech reached an agreement with multiple groups to run a Phase II clinical trial; and Insys licensed a drug candidate from Gold Coast Therapeutics to treat chronic pelvic pain. Details are in the table below.

Companies	Assets	Deal terms
Ipsen, Paris; Canbex Therapeutics, London	Canbex granted Ipsen an option to purchase the company, a spin-off from University College London (UCL), upon completion of a Phase IIa study in multiple sclerosis for VSN16R, a small molecule for the treatment of spasticity in MS and other disorders.	Canbex raised £2.3m in 2013 from MS Ventures, the Wellcome Trust and UCL Business. Ipsen paid the company a €6m option fee and it will pay Canbex investors up to €90m in acquisition and milestone fees plus royalties if Ipsen exercises its option to buy the company.
Cipher Pharmaceuticals, Mississauga, Ontario, Canada; Astion Pharma, Denmark	Cipher acquired from Astion the rights to three products for inflammatory dermatological diseases: Dermadexin and Pruridexin creams, which are Class III medical devices in the EU that are approved or pending approval for seborrheic dermatitis and chronic pruritus, respectively; and ASF-1096, a Phase II lupus drug candidate. Cipher will pursue US approval for Dermadexin and Pruridexin in the first half of 2015.	Astion will receive Can$6m up front, a Can$2.5m milestone fee upon US approval and commercialization for either Dermadexin or Pruridexin, and up to $31.5m in clinical, regulatory, commercialization and sales milestone fees in the US and other regions.
Aduro Biotech, Berkeley, California	Aduro's immuno-oncology therapies GVAX Pancreas and CRS-207 are being tested in combination with the Bristol-Myers Squibb PD-1 inhibitor Opdivo (nivolumab) in an investigator-sponsored Phase II clinical trial. The trial will enroll 88 patients with metastatic pancreatic cancer who've had one prior round of chemotherapy.	The study is supported by Stand Up to Cancer-Lustgarten Foundation Pancreatic Cancer Convergence Dream Team Translational Research; Pancreatic Cancer Action Network-AACR Research Acceleration Network Grant, supported by Fredman Family Foundation; and Bristol-Myers. Aduro won a breakthrough therapy designation from the FDA in mid-2014 for CRS-207 plus GVAX Pancreas, a combination that is under evaluation in the 240-patient Phase IIb ECLIPSE study (scripintelligence.com, 25 July 2014).
Insys Therapeutics, Phoenix, Arizona; Gold Coast Therapeutics	Insys sub-licensed a novel combination of cromolyn sodium and cetirizine for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), which Gold Coast licensed from Northwestern University. Preclinical and clinical studies are in the design phase.	Undisclosed

Alkermes drops pain drug after Phase I study

Alkermes said on 24 February that it will no longer pursue development of ALKS 7106 after it reviewed the results of a Phase I clinical trial. The Dublin-based company said the novel pain drug candidate did not meet pre-specified criteria for advancing ALKS 7106 into Phase II following a placebo-controlled study to evaluate safety, tolerability and pharmacokinetics of single escalating doses in 64 healthy volunteers. Alkermes will continue to develop pain medicines with low potential for overdose and abuse, but it will now focus on backup compounds.